Treatment Protocols for Patients With Symptomatic Oral Lichen Planus

NCT04673916 | Completed DMC

• 1 other identifier: 121/120/PO
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study was to compare the therapeutic efficacy of clobetasol propionate 0.05% oral gel versus an anti-inflammatory mouthwash in an oral solution for the management of patients suffering from symptomatic OLP. The secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects.

Conditions

Lichen Planus, Oral; Preneoplastic Condition

Outcome Measures

Primary Outcomes (1)

• Clinical Mucosal healing

  Patients clinically were evaluated using the scale used by Thongprasom et al. as reference. This gives a score that varies from 0 to 5, using a millimetre reference: 0, in the absence of lesions; 1, in the presence of hyperkeratosis streaks; 2, in the presence of an atrophic area less than 1 mm2; 3, in the presence of an atrophic area greater than 1 mm2; 4, in the presence of an erosive area less than 1 mm2; 5, in the presence of an erosive area greater than 1 mm2. In the presence of multiple injuries, the value has been calculated by summing the values of each injury.

  180 days

Study Arms (2)

Clobetasol treatment

ACTIVE COMPARATOR

The clobetasol group was treated with clobetasol propionate 0.05%, while the anti-inflammatory group was treated with mouthwash. The drug used consisted of Clobetasol propionate 0.05%, Ethyl alcohol 96° (50%), Hydroxyethylcellulose (4%); Preserved water (just enough to 100%) that was topically applied \[11\]. This drug was produced as a galenic formulation. Clobetasol propionate twice a day (every 12 hours) to the lesions with a soft bristle brush and were advised not to drink or eat during the hour following application of the medication.

Drug: Healing evaluation

Anti-inflammatory mouthwash

ACTIVE COMPARATOR

In patients of the anti-inflammatory group, the mouthwash was used pure and without dilution at a dosage of 20 ml 3 times a day, immediately after normal daily oral hygiene was prescribed. It contains calcium hydroxide, hyaluronic acid, Umbelliferone and Oligomeric Proanthocyanidins. Patients were instructed to rinse for at least 5 minutes over the entire oral mucosa, with particular emphasis on the regions where the lesions are located.

Drug: Healing evaluation

Interventions

Healing evaluation DRUG

Treatments were topically applied for 5 days

Anti-inflammatory mouthwash; Clobetasol treatment

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years;
• clinical diagnosis and histological diagnosis of OLP on the basis of WHO criteria;
• presence of symptoms related to OLP.

You may not qualify if:

• presence of systemic conditions that may have affected the study results;
• state of pregnancy or breastfeeding;
• histological signs of dysplasia;
• drugs inducing a lichen response (ACE-inhibitors, β-blockers, etc.);
• treatment of OLP in the six months prior to the start of the programme;
• presence of extraoral lesions (genital, skin and other)
• history of previous immunodeficiency or HIV seropositivity;
• previous allogeneic bone marrow transplantation;
• presence of systemic lupus erythematosus or other autoimmune diseases.

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

University of Messina

Messina, 98100, Italy

Location

Related Publications (1)

• Santonocito S, Polizzi A, De Pasquale R, Ronsivalle V, Lo Giudice A, Isola G. Analysis of the Efficacy of Two Treatment Protocols for Patients with Symptomatic Oral Lichen Planus: A Randomized Clinical Trial. Int J Environ Res Public Health. 2020 Dec 23;18(1):56. doi: 10.3390/ijerph18010056.

  PMID: 33374791 DERIVED

MeSH Terms

Conditions

Lichen Planus, Oral; Precancerous Conditions

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 2 groups of patients

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: June 1, 2019
• Primary Completion: February 15, 2020
• Study Completion: June 25, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year
• Access Criteria: University website and pubmed

Locations

IT (1)